The following data is part of a premarket notification filed by Diadexus, Inc. with the FDA for Diadexus Plac Test.
| Device ID | K050523 |
| 510k Number | K050523 |
| Device Name: | DIADEXUS PLAC TEST |
| Classification | Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 |
| Applicant | DIADEXUS, INC. 343 OYSTER POINT BLVD. South San Francisco, CA 94080 |
| Contact | Julie Blacklock |
| Correspondent | Julie Blacklock DIADEXUS, INC. 343 OYSTER POINT BLVD. South San Francisco, CA 94080 |
| Product Code | NOE |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-02 |
| Decision Date | 2005-06-15 |
| Summary: | summary |